Psychological Symptoms in Cardiac and Pulmonary Diseases

June 19, 2024 updated by: Istituti Clinici Scientifici Maugeri SpA

Prevalence of Psychological Symptoms and Their Correlation With the Rehabilitative Outcome in Patients With Cardiac and Pulmonary Diseases Undergoing a Hospital Rehabilitation.

The European guidelines emphasize the importance of conducting psychological screenings to investigate the presence of stress and symptoms of anxiety and depression in patients with cardiovascular disease: depression, common among patients with CVD, is associated with increased mortality, disability, decreased adherence to healthy lifestyles and medical treatments, and together with anxiety, the risk of mortality increases by about 3 times; stress, furthermore, is associated with the development and progression of cardiovascular diseases and is correlated with low adherence and cigarette smoking.

Less studied, but not less important, are the incidence of anxiety, depression, and stress in pulmonary disease, the relationship between mental disorders and pulmonary diseases, as well as the effect of the psychological component on the rehabilitative outcome of such patients: for example, there is evidence that those suffering from chronic obstructive pulmonary disease (COPD) present symptoms of depression and anxiety much more frequently than the general population and that these two mental disorders may exacerbate COPD itself.

The literature, therefore, highlights that the risk of onset of cardiovascular disease increases with the severity of mental disorder, and some psychological variables correlate with the outcomes of cardiac rehabilitation intervention, crucial for reducing rehospitalizations, myocardial infarction, and mortality, as well as for improving the patient's quality of life and ability to perform physical exercises.

In light of this evidence and the recent recommendations of the ESC, the present study aims to conduct screening for symptoms of anxiety, depression, and stress in all patients admitted to the Cardiology and Pulmonary Rehabilitation Units of the Milan Center, Camaldoli in order to assess their incidence and to select, through validated tools, patients who require personalized psychological intervention based on their level of risk, correlating then the presence of such symptoms with the rehabilitative outcome, in order to assess how much the mental component interferes with the care pathway. The level of acceptance and feasibility of a computerized data collection procedure will also be evaluated, a procedure that, if well accepted, would make the screening process much simpler, safer, and more economical.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

421

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20138
        • ICS Maugeri SpA SB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients admitted to the ICS Maugeri Cardiology and Pulmonary Rehabilitation Units

Description

Inclusion Criteria:

  • aged≥18
  • able to fulfil questionnaires autonomously

Exclusion Criteria:

  • no Italian comprehension,
  • severe visuoperceptive deficits,
  • cognitive deterioration preventing self-completion of questionnaires,
  • refusal to underwent to the evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cardio-respiratory
Inpatients affected by cardiac or pulmonary diseases undergoing a rehabilitative program
Other: no intervention because it is an observational study
it is an observational study thus there is no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of psychological risk and protective factors
Time Frame: 18 months
To conduct a screening of anxious, depressive, stress symptoms and coping strategies in patients admitted a Cardiology and pulmonary Rehabilitation Units
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlations between psychological variables and rehabilitative outcomes
Time Frame: 18 months
To correlate risk and protective factors with rehabilitative outcomes
18 months
Acceptance of computerized screening
Time Frame: 18 months
The degree of acceptance of an online data collection procedure will be evaluated.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Investigators

  • Principal Investigator: Alessandra Gorini, PhD, ICS Maugeri SpA SB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Actual)

May 15, 2024

Study Completion (Actual)

May 31, 2024

Study Registration Dates

First Submitted

April 30, 2024

First Submitted That Met QC Criteria

April 30, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Actual)

June 21, 2024

Last Update Submitted That Met QC Criteria

June 19, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEC N. 2695

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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